Clinical Data Manager I — SDTM & Data Transfer

RXinsider LTD.; Wilmington (MA); On-site; USD 64,000 - 68,000; Full time

Benefits offered by this job

Bonus incentives

401K

Paid time off

Stock purchase program

Health coverage

Job summary

Charles River seeks a Clinical Data Manager I to oversee basic clinical trial data across studies within Safety Assessment. You will coordinate data life cycle, ensure timely reporting, and collaborate with site operations and clients to maintain high data quality.

The role requires a BS/BA in a scientific field and 3–5 years in pharma data management, with familiarity in CDISC standards and various data formats. Competitive compensation and benefits apply.

Qualifications

• Bachelor’s degree in a scientific discipline; 3-5 years in a research or pharmaceutical environment; data management experience preferred.
• Familiarity with CDISC’s CDASH, SDTM, and Controlled Terminology Standards.
• Familiarity with data output formats (.xml, .xpt, sas7bdat, ASCII, text, .DAT, .xlsx).
• Proficient in Microsoft Office; strong organization and deadline skills.
• Excellent written and verbal communication and collaboration.

Responsibilities

• Request sponsor requirements for transfer frequency and dataset architecture.
• Prepare and/or review Data Transfer Agreements for basic assay data types.
• Oversee preparation of the Study Data Tabulation Model (SDTM) and non-SDTM datasets.
• Perform quality control on clinical study data and regulatory compliance tasks.
• Confirm datasets are transferred to the sponsor per regulations.

Skills

Data management

CDISC CDASH SDTM

Communication skills

Organizational skills

Regulatory compliance

Client interaction

Microsoft Office

Education

Bachelor’s Degree (B.S./B.A.) in scientific discipline

Tools

Microsoft Office Suite

Job description

Charles River seeks a Clinical Data Manager I to oversee basic clinical trial data across studies within Safety Assessment. You will coordinate data life cycle, ensure timely reporting, and collaborate with site operations and clients to maintain high data quality.

The role requires a BS/BA in a scientific field and 3–5 years in pharma data management, with familiarity in CDISC standards and various data formats. Competitive compensation and benefits apply.